Medical Device Regulatory Affairs Specialist

2 days ago

canada Wellnest Health Monitoring Pvt. Ltd. Full-time $95,000

Medical device regulatory submissions require technical writing and compliance expertise at Wellnest. Support USA, Canada, and Europe submissions while managing regulatory requirements.

As a Regulatory Affairs Specialist, you will research, write, analyze, edit, and compile technical documents for country-specific submissions. You will communicate requirements across departments, support manufacturing processes, and address regulatory authority inquiries. The work includes device incidents, labels, promotional materials, audits, and applicable guidance.

Key Responsibilities:

  • Research and compile technical regulatory submission documents
  • Support manufacturing process setup and model changes
  • Prepare responses to regulatory authority questions
  • Assess device incidents and submit reportable events
  • Review labels and promotional materials for compliance

Requirements:

  • Two to five years of experience
  • Knowledge of manufacturing licensing and CDSCO
  • Experience with applicable ISO standards
  • Ability to lead startup regulatory processes independently
  • Medical device approval experience is an advantage

Apply regulatory writing, compliance, manufacturing, and incident assessment skills across Wellnest medical device submissions.

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